ELEOS Limb Salvage System with BioGrip
K-Number: K203815 · 2021-06-09
ApplicantOnkos Surgical
Decision Date2021-06-09
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
ELEOS Limb Salvage System with BioGrip is a medical device manufactured by Onkos Surgical. It received FDA 510(k) clearance on 2021-06-09 under approval number K203815. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ELEOS Limb Salvage System with BioGrip?
ELEOS Limb Salvage System with BioGrip is a medical device that received FDA 510(k) clearance on 2021-06-09. It is manufactured by Onkos Surgical. The 510(k) number is K203815.
When was ELEOS Limb Salvage System with BioGrip approved by the FDA?
ELEOS Limb Salvage System with BioGrip received FDA 510(k) clearance on 2021-06-09, under approval number K203815.
What company makes ELEOS Limb Salvage System with BioGrip?
ELEOS Limb Salvage System with BioGrip is manufactured by Onkos Surgical.
What is the FDA product code for ELEOS Limb Salvage System with BioGrip?
The FDA product code for ELEOS Limb Salvage System with BioGrip is JDI.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.